MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXTRACTOR PRO RX; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00547020
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient with history of cardiac arrest and recent choledocholithiasis was admitted for a endoscopic retrograde cholangiopancreatography, sphincterotomy, stone removal and stent replacement.Boston scientific extractor" pro rx retrieval balloon catheter was difficult to inflate.Once it did inflate, it lost air.The extractor" pro rx retrieval balloon catheter was removed without known harm to the patient, and another device was used for procedure.Upon examination, it was observed that the catheter above the balloon had a slit and was defective.

• Brand Name: EXTRACTOR PRO RX
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12056984
• Report Number: 12056984
• Device Sequence Number: 4250206
• Product Code: FGE
• UDI-Device Identifier: 08714729790310
• UDI-Public: (01)08714729790310(17)230209(10)26777266
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/17/2021
• Report Date (Section F): 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00547020
• Device Catalogue Number: M00547020
• Device Lot Number: 26777266
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2021
• Patient Sequence Number: 1
• Patient Weight: 103
• Date Report Sent to FDA: 06/17/2021